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Meditend Import House (Pty) Ltd

✅ Low Risk

FEI: 3004106819 • Durbanville, Western Cape • SOUTH AFRICA

FEI

FEI Number

3004106819

📍

Location

Durbanville, Western Cape

🇿🇦
🏢

Address

PO Box 172, , Durbanville, Western Cape, South Africa

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
3
Unique Violations
10/27/2003
Latest Refusal
10/27/2003
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
10/27/2003
81LOQDEVICE, GENERAL PURPOSE HEMATOLOGY
118NOT LISTED
341REGISTERED
508NO 510(K)
New York District Office (NYK-DO)

Frequently Asked Questions

What is Meditend Import House (Pty) Ltd's FDA import refusal history?

Meditend Import House (Pty) Ltd (FEI: 3004106819) has 1 FDA import refusal record(s) in our database, spanning from 10/27/2003 to 10/27/2003.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Meditend Import House (Pty) Ltd's FEI number is 3004106819.

What types of violations has Meditend Import House (Pty) Ltd received?

Meditend Import House (Pty) Ltd has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Meditend Import House (Pty) Ltd come from?

All FDA import refusal data for Meditend Import House (Pty) Ltd is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.